The First Digital Pill Gets FDA Approval

The first regulators have approved the first digital pill that has the ability to monitor whether patients with mental illness are adhering to their prescriptions.

The decision marks a milestone in the mergence of technology and health care but also raises privacy concerns of patients.

The pill is said to be based off a version of Otsuka Pharmaceutical Co.’s Abilify, which is used for treatment of depression, bipolar disorder and schizophrenia. Stomach fluids activate the digital pill and send a signal to the patch worn on the patients torso, transmitting the information to a smartphone app monitored by physicians.

Allowing physicians to monitor patient’s use, is what chief executive officer for North America at Otsuka Pharmaceutical says will enable them to prevent “dramatic and immediate health-care crises, such as for schizophrenia patients where missing medicines can result in a psychotic break which will land them in an ER.” Through the app patients rest and mood information will also be shared with their physician.

While the advancement is being embraced by the health industry, many are more concerned with their privacy.

If prescribed the product referred to as Abilify MyCite, patients have to agree that the information can be shared with their physician. The will also have the ability to give consent to family members.

The program is expected to have a limited start with only a handful of health systems gathering evidence on the drug’s effects, but will have the long term effect of patients wondering exactly where all of the data is going and if it can be accessed by others for other means.